MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-17 for LINA GOLD LOOP EL-240-8 manufactured by Lina Medical Usa.
[31354649]
Patient Sequence No: 1, Text Type: N, H10
[31354650]
The wire on the gold loop broke preventing amputation of the uterus from the cervix. A second loop was opened to complete the amputation. The manufacturer opened a complaint file and asked follow-up questions. Manufacturer intends to send a shipping label for the device to be returned for a full investigation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5229184 |
| MDR Report Key | 5229184 |
| Date Received | 2015-11-17 |
| Date of Report | 2015-11-05 |
| Date of Event | 2015-10-30 |
| Report Date | 2015-11-05 |
| Date Reported to FDA | 2015-11-05 |
| Date Reported to Mfgr | 2015-11-05 |
| Date Added to Maude | 2015-11-17 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LINA GOLD LOOP |
| Generic Name | COAGULATOR-CUTTER, ENDOSCOPIC |
| Product Code | HIN |
| Date Received | 2015-11-17 |
| Catalog Number | EL-240-8 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LINA MEDICAL USA |
| Manufacturer Address | 816 CONGRESS AVENUE SUITE 1400 AUSTIN TX 78701 US 78701 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-11-17 |